MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B113
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant med products- stratafix pds plus, vicryl plus suture, stratafix spiral pdo, stratafix spiral monocryl plus, prineo.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a knee arthroplasty procedure on (b)(6) 2018 and suture was used.Post operatively, one day after the procedure, the patient presented with wound dehiscence.The closures are done by the pa from capsule to skin.Additional information from the surgeon indicates that the pa was not going as deep with the deep dermal bites and had an error in usage and does not opine that there was any product failure.The dehiscence was most likely subcuticular and not deeper.The wound was re-sutured closed in the office and the patients current condition is fine.
Additional Manufacturer Narrative
(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Date sent to the fda: 02/27/2018.

• Brand Name: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7296439
• Report Number: 2210968-2018-71042
• Device Sequence Number: 1249956
• Product Code: GAM
• UDI-Device Identifier: 10705031236721
• UDI-Public: 10705031236721
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: SXMP1B113
• Device Lot Number: KEH154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 02/26/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 02/27/2018; 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention